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. Author manuscript; available in PMC: 2021 Sep 24.
Published in final edited form as: Lancet Oncol. 2020 Mar 20;21(5):671–684. doi: 10.1016/S1470-2045(20)30109-1

Table 2:

Primary and secondary efficacy outcomes

FGFR2 fusions or rearrangements (n=107) Other FGF/FGFR alterations (n=20) No FGF/FGFR alterations (n=18)
Proportion of patients with an objective response 35·5% (26·5 to 45·4) 0 0
Best overall response*
 Complete response 3 (2·8%) 0 0
 Partial response 35 (32·7%) 0 0
 Stable disease 50 (46·7%) 8 (40·0%) 4 (22·2%)
 Progressive disease 16 (14·9%) 7 (35·0%) 11 (61·1%)
 Not evaluable 3 (2·8%) 5 (25·0%) 3 (16·7%)
Duration of response
 Patients with events 21/38 (55%) 0 0
 Patients censored 17/38 (45%) 0 0
 Median duration of response, months 7·5 (5·7 to 14·5) .. ..
 Kaplan-Meier estimated probability of retaining a response
  At 6 months 68% (49 to 82) .. ..
  At 12 months 37% (19 to 56) .. ..
Proportion of patients with disease control 82% (74 to 89) 40% (19 to 64) 22% (6 to 48)
Progression-free survival
 Patients with events 71 (66%) 17 (85%) 16 (89%)
 Patients censored 36 (34%) 3 (15%) 2 (11%)
 Median, months 6·9 (6·2 to 9·6) 2·1 (1·2 to 4·9) 1·7 (1·3 to 1·8)
 Kaplan-Meier estimates of progression-free survival
  At 6 months 62% (52 to 70) 25% (8 to 47) 6% (<1 to 25)
  At 12 months 29% (19 to 40) 0 0
Overall survival
 Patients with events 40 (37%) 16 (80%) 14 (78%)
 Patients censored 67 (63%) 4 (20%) 4 (22%)
 Median overall survival, months 21·1 (14·8 to not estimable) 6·7 (2·1 to 10·6) 4·0 (2·3 to 6·5)
 Kaplan-Meier estimates of overall survival
  At 6 months 89% (81 to 93) 51% (26 to 71) 31% (11 to 54)
  At 12 months 68% (56 to 76) 23% (7 to 43) 13% (2 to 33)

Data are % (95% CI), n (%), or months (95% CI). FGFR=fibroblast growth factor receptor.

*

Assessed and response confirmed by independent reviewer (95% CIs not available for individual response values).

Overall survival data were not mature at data cutoff.